MedDataX Logo

Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.

NCT ID: NCT01250782

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients.

The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality.

This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: To evaluate the efficacy of the endovenous administration endovenous glutamine to reduce the number of infectious complications, mortality and ICU length of stay in trauma ICU patients. To achieve this objective we have designed this pilot study to obtain the necessary data to design a bigger trial in the future.

Other objectives include:

* To evaluate the efficacy of glutamine in different patients regarding their severity: patients with an Injury Severity Score\> 25 and patients with lower plasma levels of glutamine.
* To registry the possible adverse events of the endovenous administration of glutamine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma ICU Patients

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Glutamine, trauma patients, infections, mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physiological Serum

Group Type PLACEBO_COMPARATOR

Physiological serum

Intervention Type DRUG

100 mL of physiological serum indistinguishable from active comparator

Glutamine

Group Type ACTIVE_COMPARATOR

Glutamine

Intervention Type DRUG

0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glutamine

0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine

Intervention Type DRUG

Physiological serum

100 mL of physiological serum indistinguishable from active comparator

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Moderate to severe trauma, as defined by an Injury Severity Score (ISS) \> 10 points were included in the study.
* Traumatic patients who required enteral or parenteral nutrition during the first 48 hours after hospital admission
* Written informed consent

Exclusion Criteria

* patients whose life expectancy was less than 5 days,
* who were allergic to glutamine,
* Patients included in any other trial
* Cirrhotic patients (Child C)
* Chronic renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitari Son Dureta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hospital Universitari Son Dureta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Son Dureta

Palma, Balearic Islands, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jon Pérez-Barcena, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GlnHSD-001-09

Identifier Type: -

Identifier Source: org_study_id